Good manufacturing practice: difference between revisions
Diff·revision 2 → 3·05:00, 10 Sep 2024
Difference between revision 2 and revision 3 of Good manufacturing practice. 5 lines changed; the page grew by 620 bytes.
| Revision 2 — 23:58, 1 Sep 2024 BiosimilarBoaz (talk) fix a broken wikilink 1,153 bytes ±0 | Revision 3 — 05:00, 10 Sep 2024 TrialsTabitha (talk) expand §What a GMP claim on a research chemical means 1,773 bytes +620 | ||
|---|---|---|---|
| 11 | GMP is jurisdictional. A claim of GMP compliance is meaningful only in relation to a regulator, a scope and a period, and "GMP-certified" without those particulars is not a checkable statement — regulators inspect and issue findings rather than issuing perpetual certificates.{{r|ich_q7}} | 11 | GMP is jurisdictional. A claim of GMP compliance is meaningful only in relation to a regulator, a scope and a period, and "GMP-certified" without those particulars is not a checkable statement — regulators inspect and issue findings rather than issuing perpetual certificates.{{r|ich_q7}} |
| 12 | 12 | ||
| + | 13 | == What GMP requires == | |
| + | 14 | The requirements cover premises and equipment, personnel and training, documentation and records, materials management, production and in-process controls, packaging and labelling, storage and distribution, laboratory controls, validation, change control, deviation and complaint handling, and recall capability.{{r|ich_q7}} | |
| + | 15 | ||
| + | 16 | Documentation is the connective tissue. A batch record contemporaneously documents what was done, by whom, with which materials, and what the in-process results were — which is what makes [[Lot traceability|traceability]] possible at all rather than merely asserted. | |
| + | 17 | ||
| 13 | == References == | 18 | == References == |
| 14 | {{reflist}} | 19 | {{reflist}} |